A Phase II Trial of Alemtuzumab (Campath-1H) and Rituximab (Rituxan) in Patients With Previously Untreated CLL
- To determine the response rate in patients with previously untreated B-cell chronic
lymphocytic leukemia treated with alemtuzumab and rituximab.
- To evaluate the toxicity of alemtuzumab and rituximab in these patients.
OUTLINE: Patients receive alemtuzumab subcutaneously on days 1, 3, and 5 in weeks 1-18 and
rituximab IV on day 1 in weeks 3, 5, 7, 9, 11, 13, 15, and 17 in the absence of disease
progression or unacceptable toxicity.
Peripheral blood and bone marrow samples are collected periodically for laboratory biomarker
studies. Samples are analyzed for surface markers (e.g., CD3, CD4, CD8, CD10, CD19, CD20,
CD25, CD38, CD52, Zap-70) and IgVH by PCR, flow cytometry, and FISH. Samples are also
analyzed for alemtuzumab and anti-alemtuzumab antibody levels by flow cytometry.
After completion of study treatment, patients are followed periodically for 5 years.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate to the study medications, Alemtuzumab and Rituximab
Response rate to the study medications, Alemtuzumab and Rituximab, will be measured at 9 weeks, 18 weeks, and 30 weeks, by physical examination and evaluation of peripheral blood and bone marrow through lab tests.
At 9 weeks (during therapy), 18 weeks (at the completion of therapy), and 30 weeks
Olga Frankfurt, MD
United States: Food and Drug Administration
|Northwestern University, Northwestern Medical Faculty Foundation||Chicago, Illinois 60611-3013|